Dosed biological material delivery devices, often referred to as ‘injection pen device’ are commonly used for routine injection of biologic materials. Hence, ‘injection pen device’ refer generally to any and all free-standing portable device containing a plurality of doses of a biological material liquid which can be operated by a patient for self injection to deliver metered doses of the liquid to the patient's body on a plurality of occasions.
Injection pen device are normally used to deliver the basal doses of biological material. Further prior art devices for basal and bolus delivery of biological materials are available wherein
(i) They deliver precisely either the basal doses of biological material or bolus doses of biological material but not both by the drive mechanism simultaneously. Pre-dominantly the drive mechanisms used are either (i) a gas source or (ii) a combination of gas source and a mechanically stored energy or (iii) a purely mechanically stored energy. In situations where purely mechanical energy is being used, either a basal delivery of biological material or bolus delivery of biological material is achieved, but not both of them.
(ii) The devices which employ only mechanical energy as a sole mechanism of delivery, it delivers only bolus or basal delivery of biological material but not both.
(iii) The devices which employ transfer of mechanical energy to hydraulic energy and back to mechanical energy achieves both bolus delivery of biological material and basal delivery of biological material.
The term ‘micro-needle’ may refer to a device for transdermal delivery or removal of fluids without many of the risks associated with standard syringes. Such devices may use arrays of small diameter micro-needles and these small diameter micro-needles may be non-biodegradable or biodegradable. The term ‘biodegradable micro-needle’ refers to micro-needles made of biodegradable polymers which include polymers of hydroxy acids such as lactic acid and glycolic acid polylactide, polyglycolide, polylactide-co-glycolide, and copolymers with PEG, poly anhydrides, poly (ortho)esters, polyurethanes, poly(butyric acid), poly (valeric acid), and poly (lactide-co-caprolactone) comprising a biological material which possesses therapeutic, prophylactic, or diagnostic properties in vivo, for example when administered to an animal, including mammals, such as humans.
Biological material delivered by these biodegradable micro-needles may provide a clinically useful alternative to standard syringes. The devices comprising biodegradable micro-needles may be known in the art for delivering a wide variety of biological materials. The amount of selected portion of biodegradable micro-needle corresponding to the dose to be delivered may vary from individual to individual. Adjusting the selected portion of biodegradable needle corresponding to the dose according to individual need is a challenging task with biodegradable micro-needles as the biological material that needs to be delivered may be fixed per micro-needle and there may be no reservoir attached for increasing the dose.
Micro-needle which is non biodegradable is designed to pierce the stratum corneum skin barrier layer in a minimally invasive and pain-free manner to provide transient pathways for the delivery of macromolecules to the underlying skin epidermis. Since the needle is short, it does not reach the nerve-rich regions of the lower parts of the skin. As a consequence, the stimulus caused by micro-needle insertion into the skin is weak and cause less pain. Such devices may use arrays of small diameter needles that each deliver relatively small flow rates of fluid across or into a biological barrier, which together with the fluid delivered by other needles in the array; provide a clinically useful alternative to standard syringes.
U.S. Pat. No. 6,702,779 discloses a wearable, self-contained drug infusion device that is capable of achieving the precise flow rate control needed for dose-critical drugs such as insulin.
U.S. Pat. No. 6,939,324 discloses fluid delivery and measurement systems and methods.
U.S. Application No. 20050119618 discloses a hydraulic pump device and its use thereof, especially in a fluid delivery system.
PCT Application No WO07115039 relates generally to fluid delivery devices and particularly to fluid delivery devices capable of delivering one or more medicaments to a patient to provide a sustained, basal delivery and/or a bolus delivery of each medicament.
U.S. Pat. Nos. 7,056,495, 6,586,006, 6,565,871, 6,331,310, 6,290,991, 6,811,792 and 6,893,657 disclose solid dose delivery systems for administration of guest substances and bioactive material to subcutaneous and intradermal tissue, the delivery vehicle being sized and shaped for penetrating the epidermis.
U.S. Pat. No. 7,141,034 relates to transdermal drug delivery device for forming a micropore in a tissue membrane of an animal comprising a substrate and a porator that is located on or within the substrate.
U.S. Pat. No. 7,083,592 relates to apparatus for delivering or withdrawing fluid, e.g. a drug, through the skin.
U.S. Application No. 20050008683 relates to a method for administration of a substance to a subject's skin comprising delivering the substance into an intra dermal compartment of the subject's skin, wherein the substance results in an immune response no greater than when the substance is delivered intramuscularly.
U.S. Application No. 20050010193 relates to a method for administration of a substance into a subject's skin, comprising delivering the substance into a junctional layer of the subject's skin.
EP Patent No. 1 880 741 A1 discloses a method for directly delivering whereby a substance is introduced into an intradermal space within mammalian skin which involves administering the substance through at least one small gauge hollow needle having an outlet with an exposed height between 0 and 1 mm.